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临床试验/NCT04648397
NCT04648397已完成不适用

The Effect of Chewing Duration on Blood Glucose Levels

Wageningen University and Research2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Blood glucose responses in the 3 hrs following lunch

研究概览

简要总结

This study aims to assess the impact of speed of consumption of two starch-based foods varying in fibre content on blood glucose levels in normal healthy subjects. Furthermore, the mediating roles of salivary amylase and particle size on blood glucose levels will be studied. The study has a randomized cross-over design. Subjects consume two test-lunches (chick peas and brown rice) in duplicate on 8 different test days, at either long or short chewing duration. Glucose responses will be monitored via a continuous glucose monitoring device and expectorated boluses will be collected during each test day for assessments of amylase activity and food particle size.

详细描述

Research suggests that high glucose level variability and large dips in glucose levels may have a negative impact on cognitive function and self-reported wellbeing. The way food is consumed (e.g. chewing duration) may regulate blood glucose levels. The underlying mechanism that links consumption speed to metabolic responses, satiation and health is largely unknown.

This study aims to assess the impact of speed of consumption of two starch-based foods varying in fibre content, on blood glucose levels in normal healthy subjects. Furthermore, the mediating roles of salivary amylase and particle size on blood glucose levels are studied.

The study has a randomized cross-over design. Each subject consumes two different test-lunches (chick peas and brown rice) in duplicate at either long or short duration. Their breakfast will be standardized during these 8 test days. For a duration of 12 days, blood glucose levels will be monitored via a continuous glucose device. Furthermore expectorated boluses will be collected for assessment of amylase activity and food particle size.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Apparently healthy men and women (based on questionnaire, self-reported)
  • Aged between 18 - 55 yrs
  • BMI between 18.5 - 30 kg/m2
  • In possession of a Smartphone running on iOS or Android

排除标准

  • Diagnosed with Diabetes mellitus type 1 or 2
  • Under treatment for neurological or psychiatric complaints, including eating disorders
  • History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
  • Use of medication/supplements that may influence the study results, such as medicines known to interfere with glucose homeostasis. This will be judged by our medical doctor
  • Following a diet or gained/lost >=5kg weight in the previous month.
  • Coeliac disease or gluten intolerance
  • Skin allergy, eczema or known sensitivity for plasters
  • use of drugs
  • Current smokers
  • Using > 14 glasses of alcohol per week
  • Having a food allergy for the test foods
  • Participation in another clinical trial at the same time
  • Suffering from a stomach emptying disorder
  • Employed by or an intern at the FHCR group of Wageningen Food & Biobased Research.

结局指标

主要结局

Blood glucose responses in the 3 hrs following lunch

时间窗: 12 days in total to cover all test days

measured by a continuous glucose monitoring device

次要结局

  • In vitro starch digestion rates in food bolus(on 4 of the 8 test days, at day 1, day 2, day 3 and day 4 or day 5, day 6, day 7 and day 8 depending on group)
  • Amylase activity(at day 1)
  • Particle size of food bolus(on 4 of the 8 test days, at day 1, day 2, day 3 and day 4 or day 5, day 6, day 7 and day 8 depending on group)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diederik Esser

Principal investigator

Wageningen University and Research

研究点 (2)

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